CONNECTING TUBE - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

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More Product Details

Catalog Number

-

Brand Name

CONNECTING TUBE

Version/Model Number

MAJ-1971

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103264

Product Code Details

Product Code

FEB

Product Code Name

ACCESSORIES, CLEANING, FOR ENDOSCOPE

Device Record Status

Public Device Record Key

574b6410-1dcf-4630-919d-f3458aa15daa

Public Version Date

December 09, 2021

Public Version Number

8

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52